FDA Adverse Event
Injury
Summary report: N
PELVICOL 2 X 4 CM
MDR report key: 3111782
·
Received April 17, 2013
Report
- Report Number
- 9617613-2013-00166
- Event Type
- Injury
- Date Received
- April 17, 2013
- Date of Event
- June 12, 2009
- Report Date
- March 20, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164913 | PELVICOL 2 X 4 CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 07B06-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other | PELVICOL ACELLULAR COLLAGEN MATRIX 4X7 CM, 482047| PELVICOL 2CM X 7CM 1.0MM, 482027, LOT#08B19-9| LOT # 07B11-4, EXPIRATION DATE: 11/28/2010| EXP DATE: 01/15/2012, MANUFACTURING DATE: 01/2010| MANUFACTURING DATE: 11/2008 |